Open-label Study of ELA026 in Participants With Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age6+
SponsorElectra Therapeutics Inc.
About this trial
Hemophagocytic lymphohistiocytosis is a rare, aggressive and life-threatening syndrome of excessive immune activation. Secondary hemophagocytic lymphohistiocytosis (sHLH) is the most common form of this disease and is typically associated with several other clinical conditions (eg, malignancy associated HLH (mHLH), infection, or autoimmune disease). ELA026 is a fully human immunoglobulin G1 (IgG1) signal regulatory protein (SIRP)-directed monoclonal antibody designed to deplete the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, efficacy pharmacokinetics and pharmacodynamics of ELA026 in participants with sHLH.
Eligibility criteria
Qualifiers
≥12 years at the time of HLH diagnosis (Cohort 1).
≥6 years at the time of HLH diagnosis (Cohort 2-3).
Treatment naïve or relapsed/refractory (Cohorts 1 and 2).
Treatment naïve or early refractory (Cohort 3).
Disqualifiers
Known or previous treatment for primary HLH
Any other significant concurrent, uncontrolled medical condition that in the opinion of the Investigator contraindicates participation in this study
Unknown trigger for sHLH
Active, relapsed/refractory malignancy for which no suitable therapies are available to treat the malignancy triggering the HLH
Trial design
Treatments tested in this trial
- ELA026
Treatment groups
156 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov